Responsible for the oversight of day-to-day study operations for assigned projects under the Project Director, working closely with the CRO and other selected vendors for the assigned project(s)
Assist in the development of clinical assets from pre-clinical through late phase clinical trials
Provide Project Directors with project status updates, data, and reports as applicable and requested
Assist with program-level strategy, timelines, trial design, and implementation (as applicable)
Accountable for developing and managing project-level plans, timelines, and site budgets (with assistance from Project Director, as appropriate)
Manage, facilitate and document project team meetings (e.g. meeting agenda, minutes, operational risk, action items and decision logs) to enable effective decision making
Manage study team communications to ensure cross-functional connectivity among study team members and supporting functional staff
Review, provide input and guide completion of CRO study related plans (i.e. project management plan, communication plan, monitoring plan, reg submission plans, training plans, risk mitigation plans, study close out plans, etc.)
Interface with Clinical Programs Leads to ensure company assets are managed effectively
Evaluate work processes on an ongoing basis to identify inefficiencies and gaps and provide solutions to resolve identified issues.
In partnership with other functional areas, participate and provide feedback to other plans (data management, medical monitoring/safety management plan, etc.); participate in UAT of systems as needed
Ensure all relevant study related documents are filed appropriately in virtual data room in a timely manner
Assist with study supply and drug management
Collaborate with external vendors and/or internal colleagues to ensure critical timepoints are met for regulatory submissions and CMC work, as appropriate
Take on responsibilities outside of specific job requirements when needed and requested